Site Regulatory Strategist

• Why Patients Need You

Were looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

As a Site Regulatory Strategist you will be part of a team that will guide Pfizer by interpreting federal state and international regulations as they apply to products processes practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Sr Manager.

You will work in cross-functional teams with different Puurs departments (manufacturing labs QA supply) and collaborate with R&D global regulatory colleagues (Global Chemistry Manufacturing & Controls (GCMC) in order to support the introduction of new products in the site.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Support regulatory submissions (MAA NDA BLA) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
• Liaise with regulatory colleagues to communicate and resolve potential issues.
• Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of Pfizer portfolio.
• Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility.
• Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
• Contribute to the completion of projects manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.

Qualifications

• Master degree in Life sciences (e.g. industrial pharmacist biomedical sciences bio-engineer..)
• Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD) with experience in regulatory (authoring CTD BLA) and quality.

• Scientific knowledge analytical skills associated with technical writing skills to issue RFT regulatory documentation
• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA FDA)
• Ability to communicate effectively verbally and in writing good negotiation and influencing skills.
• Dynamic flexible enthusiastic and eager to learn
• Ability to work under minimal supervision and in a team
• Fluent in written and spoken English and Dutch

Pfizers doel is om gelijke kansen te bieden in het wervingsproces door elke vorm van vooringenomenheid of mogelijke discriminatie te vermijden ongeacht (maar niet beperkt tot) geslacht leeftijd ras religie of overtuiging seksuele geaardheid of handicap. We creren een organisatie en bevorderen een cultuur die respect heeft voor ieders unieke karakter en levenservaringen en die de diversiteit van onze samenleving klanten en markten weerspiegelt. Dit bereiken we door een omgeving te cultiveren en in stand te houden waarin elke collega zich gewaardeerd en ondersteund voelt.

Disability Inclusion:

Onze missie is om de kracht van al onze mensen te ontwikkelen en ruimte te geven. We zijn trots om een inclusieve werkgever te zijn die aan alle kandidaten met een beperking gelijke kansen biedt. We moedigen je aan om jezelf te zijn en dat met ons te delen wetende dat wij ons best gaan doen om jouw sollicitatie en toekomstige carrire te ondersteunen. Jouw reis bij Pfizer begint hier!